Xeleris 3.1 Processing and Review Workstation
FDA 510(k) K130884 · Ge Medical Systems F.I. Haifa
510(k) numberK130884
Submission
- Device name
- Xeleris 3.1 Processing and Review Workstation
- Applicant
- Ge Medical Systems F.I. Haifa
Tirat Hacarmel, IL - Received
- March 29, 2013
- Decision date
- April 12, 2013
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
- Third-party review
- Yes
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Questions and answers
When was Xeleris 3.1 Processing and Review Workstation cleared by the FDA?
Xeleris 3.1 Processing and Review Workstation (K130884) received a 510(k) decision of Substantially Equivalent on April 12, 2013, 14 days after the submission was received.
What is the product code of K130884?
The FDA product code is LLZ – System, Image Processing, Radiological, a Class II (moderate risk) device regulated under 21 CFR 892.2050.